Agency: Food and Drug Administration

Years: 20002001200220032004200520062007200820092010201120122013

Pages: 12345>»

[FR Doc E9-26966] 26. Current Good Manufacturing Practice Requirements for Combination Products;

The Food and Drug Administration (FDA) is extending to February 5, 2010, the comment period for the proposed rule that appeared in the Federal Register of September 23, 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action

Published: 2009-11-10 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26760] 27. Agency Information Collection Activities: Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed

Published: 2009-11-06 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26850] 28. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-11-06 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26674] 29. Amendment to Memorandum of Understanding Between the Food and Drug

The Food and Drug Administration (FDA) is providing notice of an amendment to a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC.

Published: 2009-11-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26530] 30. Food and Drug Administration's Safe Use Initiative; Availability of

The Food and Drug Administration (FDA) is announcing the launch of its Safe Use Initiative with the release of a report titled ``FDA's Safe Use InitiativeCollaborating to Reduce Preventable Harm from Medicines.'' FDA is opening a docket to enable the public to comment on the report and the initiative. In addition, a safe use Web site has been

Published: 2009-11-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26466] 31. Draft Guidance for Industry on Listing of Ingredients in Tobacco Products;

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The draft guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by section 904 of the Federal Food, Drug, and Cosmetic Act (the

Published: 2009-11-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26290] 32. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days

Published: 2009-11-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26307] 33. Agency Information Collection Activities; Submission for Office of Management

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Published: 2009-11-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26291] 34. Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients.

Published: 2009-11-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-26095] 35. Investigational New Drug Applications; Technical Amendment

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the

Published: 2009-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25915] 36. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25927] 37. Agency Information Collection Activities; Submission for Office of Management

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Published: 2009-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25804] 38. Prescription Drug User Fee Rates for Fiscal Year 2010; Correction

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.

Published: 2009-10-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25604] 39. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25671] 40. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and including each

Published: 2009-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25517] 41. New Animal Drug Applications

The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same

Published: 2009-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25518] 42. New Animal Drug Applications

The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. Currently, the regulation requires

Published: 2009-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25537] 43. Agency Information Collection Activities; Proposed Collection;

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25538] 44. Agency Information Collection Activities; Proposed Collection;

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25539] 45. Agency Information Collection Activities; Proposed Collection;

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25395] 46. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25100] 47. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25102] 48. Agency Information Collection Activities; Submission for Office of Management

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Published: 2009-10-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25177] 49. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

[FR Doc E9-25178] 50. Agency Information Collection Activities; Proposed Collection; Comment

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

Published: 2009-10-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

 

Years: 20002001200220032004200520062007200820092010201120122013

Pages: 12345>»